Senior Validation Engineer - GxP & CSV (Remote)

somewhere; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

somewhere is seeking a GxP Validation Engineer to lead validation of systems, equipment, utilities, and facilities within a regulated CSV/CQV program. This remote role collaborates with QA, IT, Manufacturing, and Facilities to keep systems audit-ready.

You will develop and execute validation plans, write risk-based documentation, and ensure 21 CFR Part 11 compliance while maintaining ALCOA+ data integrity across the lifecycle.

Qualifications

• Bachelor's degree in engineering, computer science, life science, or related field.
• Minimum of 5 years of equipment qualification and validation experience in pharma/biopharma/medical devices.
• Minimum of 3 years of Computer System Validation experience.
• Hands-on experience across equipment, systems, cleaning, process and utility validation.
• Experience validating GAMP 5 Category 4 and 5 software systems.
• Working knowledge of 21 CFR Part 11 and electronic records/electronic signatures.
• Strong command of ISPE C&Q lifecycle and data integrity ALCOA+.
• Exceptional technical writing skills with audit-ready validation documentation.

Responsibilities

• Support development and implementation of validation strategies aligned with ISPE C&Q Baseline Guide and FDA expectations.
• Maintain Validation Master Plans (VMPs) and project-level validation plans.
• Participate in system impact assessments and equipment classification.
• Apply a risk-based approach across qualification and validation activities.
• Develop, review, and execute qualification documentation (DR, DQ, IQ, OQ, PQ).
• Author and maintain requirements specifications, traceability matrices, and validation summaries.
• Execute temperature mapping and utility system qualification activities.
• Plan and execute process validation and cleaning validation for GxP manufacturing.
• Assess regulatory and data integrity requirements (21 CFR Part 11, ERES).

Skills

Technical writing

Cross-functional collaboration

Project management

GAMP 5 knowledge

Education

Bachelor's degree in engineering or life sciences

Tools

Automated testing frameworks

Job description

somewhere is seeking a GxP Validation Engineer to lead validation of systems, equipment, utilities, and facilities within a regulated CSV/CQV program. This remote role collaborates with QA, IT, Manufacturing, and Facilities to keep systems audit-ready.

You will develop and execute validation plans, write risk-based documentation, and ensure 21 CFR Part 11 compliance while maintaining ALCOA+ data integrity across the lifecycle.